450 Patient Global Oncology Trial
Clinicology was tasked with overseeing a Phase 3 oncology trial which had previously been managed by a large CRO. With the clinical team aiming to recruit 450 patients across 8 countries and 43 trial sites, Clinicology was brought in to minimise delays in global trial setup and boost recruitment of suitable trial participants.
There are many challenges involved in setting up global clinical trials, and the clinical team had already encountered a number of obstacles along the way. By the time Clinicology became involved, setup was already behind by approximately 6 months, which meant that the team had not been able to fully roll out their planned recruitment processes. Delays in initial setup were resulting in delays in recruitment, increasing the risk of ongoing delays across other aspects of the trial.
At Clinicology, we took an action-oriented approach that focused on initial site setup first. Thanks to our highly experienced team including CRAs and PMs with local knowledge and contacts within regulatory agencies to expedite our requests, the first site was up and running in under two months, allowing the team to begin recruitment processes.
We also focused on site feasibility from day one, and within one week the first pre-study visit was performed. The results of this study indicated that more sites were required, which we were able to add quickly. To avoid the possibility of lengthy delays further down the road, site contracts and budgets were outlined at an early stage during the site identification process, with contracts ready for signatures as soon as local regulatory approval arrived. In addition we added two further European countries to the trial to help the clinical team regain some of the time that had been lost to recruitment.
Outside of the site setup challenges, the clinical team opted to utilize the Clinicology helpdesk, taking the administrative pressure off research staff, freeing them to focus on core tasks, leaving enquiries and base level administration to our own experts.
Through the combined efforts of our experienced team, we delivered enhanced recruitment numbers, kept protocol deviations to a minimum, and facilitated an all-round successful study.
This important oncology study was successfully completed in early 2021 with the help of our trusted team of CRAs who have worked with us before on many projects. All of those skilled individuals within our network have been hand selected for their diligence in data review, vast experience and excellent communication skills, all of which enable them to jump in to any project and deliver real value when you need them.